Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 4, 2005 | Orphan Designation: Prevention or attenuation of primary cytomegalovirus disease in immunosuppressed recipients of organ transplants. Approved Labeled Indication: #1) Attenuation of primary CMV disease associated with kidney transplant recipients who are seronegative for CMV and who receive a kidney from a CMV seropositve donor; #2) Prophylaxis of CMV disease associated transplantation of kidney (all other), lung, liver, pancreas and heart. |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 4, 2005 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Kamada Ltd.
Hepagam B (Injection) (Intramuscular) Hepatitis B Immune Globulin (Human)
NDA Applicant: Kamada Ltd. BLA No.: 125035 Prod. No.: 001 Rx (>1560IU/5ML); 002 Rx (>312IU/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 6, 2014 | Orphan Designation: Prevention of hepatitis B recurrence following orthotopic liver transplant Approved Labeled Indication: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients |
Kamada Ltd.
Hepagam B (Injection) (Intravenous) Hepatitis B Immune Globulin Intravenous (Human)
NDA Applicant: Kamada Ltd. BLA No.: 125237 Prod. No.: 001 Rx (>312IU/ML); 002 Rx (>1560IU/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 6, 2014 | Orphan Designation: Prevention of hepatitis B recurrence following orthotopic liver transplant Approved Labeled Indication: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients |
Kamada Ltd.
Varizig (For Injection) (Intramuscular) Varicella Zoster Immune Globulin (Human)
NDA Applicant: Kamada Ltd. BLA No.: 125430 Prod. No.: 002 Rx (125IU) BLA No.: 125430 Prod. No.: 001 Disc (125IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 20, 2019 | Orphan Designation: Passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella Approved Labeled Indication: Post exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella |
Kamada Ltd.
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (For Injection) (Intravenous; Intramuscular) Rho(D) Immune Globulin Intravenous (Human)
NDA Applicant: Kamada Ltd. BLA No.: 103649 Prod. No.: 004 Rx (600IU); 005 Rx (1500IU); 007 Rx (5000IU); 013 Rx (600IU); 014 Rx (1500IU); 016 Rx (5000IU) BLA No.: 103649 Prod. No.: 001 Disc (600IU); 002 Disc (1500IU); 003 Disc (5,000IU); 006 Disc (2500IU); 008 Disc (15000IU); 009 Disc (3000IU); 010 Disc (600IU); 011 Disc (1500IU); 012 Disc (5,000IU); 015 Disc (2500IU); 017 Disc (15000IU); 018 Disc (3000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 24, 2002 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Kiniksa Pharmaceuticals (UK), Ltd.
Arcalyst (For Injection) (Subcutaneous) rilonacept
NDA Applicant: Kiniksa Pharmaceuticals (UK), Ltd. BLA No.: 125249 Prod. No.: 001 Rx (220MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 27, 2015 | Orphan Designation: Treatment of CIAS1-Associated Periodic Syndromes Approved Labeled Indication: Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS) |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2028 | Orphan Designation: Treatment of pericarditis Approved Labeled Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older Exclusivity Protected Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older |
Kite Pharma Inc.
Tecartus (For Injection) (Intravenous) Brexucabtagene Autoleucel
NDA Applicant: Kite Pharma Inc. BLA No.: 125703 Prod. No.: 001 Rx (2_10^6 CAR-positive viable T cells per kg body weight)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 24, 2027 | Orphan Designation: Treatment of mantle cell lymphoma. Approved Labeled Indication: TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) Exclusivity Protected Indication: TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 1, 2028 | Orphan Designation: Treatment of acute lymphoblastic leukemia (ALL) Approved Labeled Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL) Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL) |
Kite Pharma Inc.
Yescarta (Injection) (Intravenous) axicabtagene ciloleucel
NDA Applicant: Kite Pharma Inc. BLA No.: 125643 Prod. No.: 001 Rx (2 _ 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of primary mediastinal B-cell lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 5, 2028 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, excluding patients with diffuse large B-cell lymphoma arising from follicular lymphoma. |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of primary mediastinal B-cell lymphoma. Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |
Krystal Biotech, Inc.
VYJUVEK (Gel) (Topical) beremagene geperpavec-svdt
NDA Applicant: Krystal Biotech, Inc. BLA No.: 125774 Prod. No.: 001 Rx (5.0x10^9 PFU/mL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 19, 2030 | Orphan Designation: Treatment of dystrophic epidermolysis bullosa Approved Labeled Indication: treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene Exclusivity Protected Indication: treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene |
Kyowa Kirin, Inc.
Crysvita (Injection) (Subcutaneous) burosumab-twza
NDA Applicant: Kyowa Kirin, Inc. BLA No.: 761068 Prod. No.: 001 Rx (10MG/ML); 002 Rx (20MG/ML); 003 Rx (30MG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 17, 2025 | Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets) Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older Exclusivity Protected Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 27, 2026 | Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets) Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. Exclusivity Protected Indication: For the treatment of X-linked hypophosphatemia (XLH) in pediatric patients 6 months of age to less than 1 year of age |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 18, 2027 | Orphan Designation: Treatment of tumor-induced osteomalacia (TIO) syndrome Approved Labeled Indication: Crysvita (burosumab-twza) is indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized. Exclusivity Protected Indication: For the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older |
Kyowa Kirin, Inc.
Poteligeo (Injection) (Intravenous) mogamulizumab-kpkc
NDA Applicant: Kyowa Kirin, Inc. BLA No.: 761051 Prod. No.: 001 Rx (20MG/5ML (4MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 8, 2025 | Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma. Approved Labeled Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_ry syndrome (SS) after at least one prior systemic therapy. Exclusivity Protected Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_ry syndrome (SS) after at least one prior systemic therapy. |